Integrated DNA Technologies (IDT) is a leader in life sciences manufacturing and developing products for the research and diagnostic market. It serves the areas of academic research, biotechnology, clinical diagnostics and pharmaceutical development. IDT synthesizes and ships an average of 36,000 custom products per day and serves more than 86,000 customers worldwide.

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With the challenges of double-digit growth; expanding into several new product markets and fulfilling FDA traceability requirements, IDT knew it needed a new business system.  Ultimately IDT selected Microsoft Dynamics AX ERP 2012 and implementation partner Edgewater Fullscope.

According to Aaron Warner, CIO, “From an integration perspective, IDT has easily combined Dynamics AX ERP with existing custom software used in our complex manufacturing environment. The consistency of interface design and familiarity of other Microsoft products greatly simplified the training requirements. Ultimately, we found the total cost of ownership to be lower than our projections.”

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Why deep industry functionality is important for chemical, food and beverage and pharmaceutical companies

While the process manufacturing market is typically categorized as large and mature, it remains one of the most competitive and dynamic segments of manufacturing. In today’s frenetic global markets, process manufacturers must evolve to meet the challenges of changing market demands, the increasing commoditization of products, and the volatility of pricing in energy and raw materials.

Industry analysts define process manufacturing as in the middle of a transformation in which established systems with deep functionality on older technology are being displaced by more sophisticated and agile systems. A modernization is clearly underway.

The stakes have never been higher for process manufacturers as they replace or upgrade their systems: they need to boost quality, efficiency, safety, and regulatory compliance for maximum productivity and process control. For the major process segments including chemicals, pharmaceuticals, food processing, pulp and paper, cosmetics and metals (industries whose business model is typically high volume, low margin), the ability to improve margins and to cost product and inventory based on the active ingredients central to their recipes are key to maintaining and improving competitive vitality.

Microsoft Dynamics AX is a leading ERP system for process manufacturers that offers broad and robust functionality, and it delivers low TCO through integration with other Microsoft products and technologies.

A new offering from Fullscope takes industry functionality to a deeper level. New Process Accelerators for Microsoft Dynamics AX provides powerful and detailed capabilities to help food and beverage, chemical and pharmaceutical manufacturers achieve the following:

  • Manage active ingredients throughout their operations by enabling them to buy raw materials and cost finished goods more precisely by potency.
  • Scale formulas up or down, automatically, by the identification of potent ingredients.
  • Track lot inheritance.
  • Define product sequencing, which is evaluated based on multiple characteristics, to reduce downtime and changeover costs in the production schedule.

Each Process Accelerator has been designed to address complex processes through an easy interface to automate activities as much as possible to reduce error.  Each one also provides flexibility for a manufacturer’s procurement, design, and regulatory compliance personnel so that they can easily value their inventory of materials for potency-dependent products, address factors that influence production, and trace with precision what was used in the production process. The idea is to automate processes for production and traceability as much as possible.

The Fullscope Process Accelerators for each industry integrate with the Process Industry layer of Microsoft Dynamics AX and provides new functionality concentrated in three basic areas:

  1. Potency, including automated batch balancing for raw materials and potency-based purchase pricing
  2. Lot genealogy
  3. Product sequencing

This article uses the word “potency,” but some process industries may use the terms assay, concentration, or even others. The underlying technology in the Process Accelerator supports these potency-like types of requirements found across the chemical, food and beverage and pharmaceutical industries.

Coming next month:  The Power of Potency

Companies in pharmaceutical and life sciences manufacturing share a technology requirement for a strong enterprise resource planning (ERP) system to enforce the common principles of validation projects. The goal of these validation projects is to demonstrate consistent, secure and traceable transactions for any product throughout all stages of its lifecycle. By examining three key pillars of applications validation, the importance of the underlying ERP system becomes evident.

Consistent Processes: Life sciences and pharmaceutical companies depend on ERP systems to help maintain consistent and repeatable quality. First and foremost, the recipes (the formula or bill or material [BOMs] and the routings) must be approved and locked into place so that when production is launched, only the authorized recipe is issued. These recipes are tied to specific documents called “operations procedures” which outline the specific materials, quantities and processes necessary to make a consistent quality product. The recipes require valid quality control testing with operational tie-ins to ensure an intermediate meets the specifications before it moves to the next operation. Any raw material, intermediate or finished product that is tested and falls outside of the pre-defined specification must immediately generate a non-conformance alert that is sent to internal stakeholders. An authorized formula, tied to its approved operations document, tied to an internal quality management application, is the first step to maintaining consistent processes.

Secure Processes: The CFR Part 11 compliance code addresses security.  ERP applications help support security requirements by applying electronic signatures to insure authorization for certain business process steps. For example, many life sciences companies lock down their formulas or BOMs in order to comply; and in most cases, authorized individuals can look and review formulas, but not change them. Electronic signatures can add another level of password requirement, so if someone tries to change or update a formula, a pop-up window requests an additional password. Electronic signatures frequently are used with formulas, BOMs, routings, quality specifications, and operations procedure documents.

Traceability:  The final pillar of control is the ability to track all components of the product from its raw material purchase through work in process to the final customer ship-to location. Many pharmaceutical manufacturers have co- and by-product issues, and some split and merge lots during the production process. It is essential for an ERP application in companies with highly regulated environments to manage both discrete (medical device manufacturing), as well as process (pharmaceutical and life sciences manufacturing) production requirements.